国际注册(上海、杭州)
面议
市辖区
刷新时间:2023-04-28
职位描述
1、The candidate must demonstrate solid working knowledge of biologics development processes.
2、Thorough understanding of FDA and EMA regulatory requirements and GMP regulation is required.
3、The c工作职责
1、Provide regulatory CMC guidance to the project teams to ensure development activities are compliant with relevant guidelines and governmental regulations.
2、Lead the preparation of CMC regulatory submissions namely INDs/BLAs applications including scientific and technical review for accuracy, soundness and regulatory appropriateness.
3、Ensure timely preparation and management of all necessary documentation for regulatory submissions.
4、Ensure that the content and format of regulatory submissions comply with applicable regulations and guidelines.
5、The candidate is expected to maintain up-to-date knowledge and expertise of relevant ICH guidelines, CFDA, FDA, and EMA regulations.
6、Responsible for establishing and maintaining internal filing template and ensure submission quality and consistency.
7、Represents WuXi Biologics in interactions with Regulatory Agencies and ******s’ RA CMC representatives.
1、The candidate must demonstrate solid working knowledge of biologics development processes.
2、Thorough understanding of FDA and EMA regulatory requirements and GMP regulation is required.
3、The candidate must be detail oriented with strong project management, problem-solving, negotiating, interpersonal, and communication skills (both written and oral).
4、The candidate must be fluent in English both written and oral.
5、Minimum BS degree in one of the relevant life sciences is desirable. Advanced degree and RAC certification are pluses.
BS degree with 8-10 years experience
MS degree with 5-8 years experience
PhD degree with 3-5 years experience
其他要求
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1人
- 注册部经理/主管
公司介绍
诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业,总部位于杭州,下属有上海、南京、广州、武汉等多家分公司,同时自主开发国内领先的猎头办公系统及医药人才网站,全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台,在欧、美、日等国家建立了海归引进平台,同时积极开展医药高等院校公益系列讲座,搭建了以人力、企业为主体的立体化咨询服务网,为医药企业人才队伍建设发挥了积极重要作用,为很多医药企业解决了高端人力之困。